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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K051780
Device Name JETLITE 5000
Applicant
J. Morita USA, Inc.
9 Mason
Irvine,  CA  92618
Applicant Contact HOWARD ROWE
Correspondent
J. Morita USA, Inc.
9 Mason
Irvine,  CA  92618
Correspondent Contact HOWARD ROWE
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received07/01/2005
Decision Date 07/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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